1. Field of the Invention
The present invention relates to devices for blocking a bodily passage, and, more particularly, to such devices for removably blocking a fallopian tube.
2. Description of Related Art
Sterilization remains the most popular contraceptive method in the United States, particularly among women, with approximately 40% of all men and women combined relying on sterilization as a contraceptive method. Based upon 1988 date approximately 600,000-700,000 female sterilizations are performed each year in the United States, with about 50% of these comprising postpartum tubal ligations via minilaparotomy.
Safe, nonpermanent physical methods of contraception are desirable for women who do not wish to or cannot take contraceptive medication. Since the intrauterine device (IUD) has been largely removed from the U.S. market, efforts have been expended to devise an effective fallopian tube plug to prevent the passage of an ovum into the uterus or of a spermatozoa toward an ovary.
Among the devices that have been disclosed are the fallopian tube plug of Heltebrandt et al. (U.K. Pat. Appl. GB 2 010 728 A), the plug and clip device of Roth et al. (U.S. Pat. No. 4,523,590), and the tubular pessary of Hamou (U.S. Pat. No. 4,579,110).
Over the past several years higher-quality flexible hysteroscopes having operating channels have become available, along with improved optics. It is believed that such devices can contribute to the development of an alternative reversible contraceptive method.
It is an object of the present invention to provide a device and method for blocking a fallopian tube.
It is an additional object to provide such a device that is removable.
It is a further object to provide such a device that is minimally invasive.
It is another object to provide such a device that is imagable to provide localization.
It is yet an additional object to provide such a device that does not cause scarification of the fallopian tube.
It is yet a further object to provide a reversible method for blocking a fallopian tube.
It is yet another object to provide such a method that can be performed on an out-patient basis with little or no anaesthesia.
An additional object is to provide a method of making a fallopian tube plug.
These objects and others are attained by the present invention, a removable fallopian tube plug that comprises an elongated shaft member that has a diameter dimensioned for insertion into a human fallopian tube. The shaft has an imagable portion located at least at each of a distal end and a proximal end.
A plurality of flexible fingerlike protrusions are affixed to at least a portion of the shaft, and are movable between a first position generally adjacent the shaft and a second position extending radially outward therefrom. The protrusions are biased to the second position and are adapted for closely engaging the fallopian tube. Further, the protrusions are arrayed radially and axially so as to form a barrier sufficient to prevent a passage of an ovum or of a spermatozoa in an axial direction.
It is preferred that the plug also comprise means for being gripped located at the proximal end in order to facilitate insertion and removal.
One of the methods of the present invention, for blocking a fallopian tube, includes grasping the plug as described above at a proximal end. The plug is then inserted through the cervix and into the ostium. The protrusions are dimensioned so as to be moved toward the first position during insertion into the tube, and then to be permitted to move toward the second position when insertion is complete to closely engage the fallopian tube wall. Finally, the plug""s proximal end is released, and the plug is permitted to remain within the tube until and if removal is desired.
The features that characterize the invention, both as to organization and method of operation, together with further objects and advantages thereof will better understood from the following description used in conjunction with the accompanying drawing. It is to be expressly understood that the drawing is for the purpose of illustration and description and is not intended as a definition of the limits of the invention. These and other objects attained, and advantages offered, by the present invention will become more fully apparent as the description that now follows is read in conjunction with the accompanying drawing.